Collection well for body fluid tester

• US 6,663,835 B2
• Filed: 10/18/2001
• Issued: 12/16/2003
• Est. Priority Date: 03/12/1999
• Status: Expired due to Term

• Current Assignee: Integ Incorporated (Johnson & Johnson)
• Original Assignee: Integ Incorporated (Johnson & Johnson)
• Inventors: Allen, John J., Racchini, Joel R.
• Primary Examiner(s): Kim, John
• Application Number:
  US10/001,776
• Publication Number:
  US 20020049390A1
• Time in Patent Office: 789 Days
• Field of Search: 422/55, 422/56, 422/100, 422/102, 600/573, 600/576, 600/578, 600/584, 600/317, 600/575, 600/577, 604/289, 606/180, 606/181, 606/182, 436/180
• US Class Current: 422/547
• CPC Class Codes: A61B 2562/0295 Strip shaped analyte sensors for apparatus classified in A61B5/145 or A61B5/157 disposable multilayered or laminated electrodes G01N27/307; details of handling chemical test elements G01N33/4875
• CPC Class Codes: A61B 5/14514 using means for aiding extraction of interstitial fluid, e.g. microneedles or suction
• CPC Class Codes: A61B 5/14532 for measuring glucose, e.g. by tissue impedance measurement
• CPC Class Codes: A61B 5/1486 using enzyme electrodes, e.g. with immobilised oxidase
• CPC Class Codes: A61B 5/150022 for capillary blood or interstitial fluid
• CPC Class Codes: A61B 5/150259 Improved gripping, e.g. with high friction pattern or projections on the housing surface or an ergonometric shape
• CPC Class Codes: A61B 5/150358 Strips for collecting blood, e.g. absorbent optical reagent test strips G01N21/8483; chemical reagent test strips G01N33/4875, G01N33/52
• CPC Class Codes: A61B 5/150389 Hollow piercing elements, e.g. canulas, needles, for piercing the skin
• CPC Class Codes: A61B 5/150519 Details of construction of hub, i.e. element used to attach the single-ended needle to a piercing device or sampling device
• CPC Class Codes: A61B 5/15105 Purely manual piercing, i.e. the user pierces the skin without the assistance of any driving means or driving devices
• CPC Class Codes: A61B 5/15142 Devices intended for single use, i.e. disposable
• CPC Class Codes: A61B 5/157 Devices characterised by integrated means for measuring characteristics of blood
• CPC Class Codes: B01L 2200/026 Fluid interfacing between devices or objects, e.g. connectors, inlet details
• CPC Class Codes: B01L 2200/0621 Control of the sequence of chambers filled or emptied
• CPC Class Codes: B01L 2200/0684 Venting, avoiding backpressure, avoid gas bubbles
• CPC Class Codes: B01L 2200/143 Quality control, feedback systems
• CPC Class Codes: B01L 2300/0645 Electrodes
• CPC Class Codes: B01L 2300/069 Absorbents; Gels to retain a fluid
• CPC Class Codes: B01L 2300/0825 Test strips
• CPC Class Codes: B01L 2300/161 Control and use of surface tension forces, e.g. hydrophobic, hydrophilic
• CPC Class Codes: B01L 2400/0406 : capillary forces
• CPC Class Codes: B01L 3/5023 : with a sample being transported to, and subsequently stored in an absorbent for analysis
• CPC Class Codes: B01L 3/5027 : by integrated microfluidic structures, i.e. dimensions of channels and chambers are such that surface tension forces are important, e.g. lab-on-a-chip B01L3/5023 takes precedence; micromixers B01F33/30; microreactors for synthesis B01J19/0093; microcapillary devices in general B81B1/00
• CPC Class Codes: B01L 3/502715 : characterised by interfacing components, e.g. fluidic, electrical, optical or mechanical interfaces
• CPC Class Codes: B01L 3/50273 : characterised by the means or forces applied to move the fluids micropumps F04B19/006, of the membrane type F04B43/043
• CPC Class Codes: B01L 3/502738 : characterised by integrated valves microvalves F16K99/0001
• CPC Class Codes: Y10T 436/2575 : Volumetric liquid transfer

Abstract

A body fluid is collected for testing for an analyte contained within the body fluid. The fluid is collected in an apparatus including a reservoir for receiving and collecting a flow of body fluid from a discharge end of a conduit. A capillary test space is in fluid flow communication with the reservoir. The capillary test space is positioned to be in contact with the fluid in the reservoir after the fluid has accumulated to a predetermined transfer volume of fluid. The capillary test space is sized to wick the fluid from the reservoir when the fluid contacts the capillary test space.

Claims

1. An apparatus for collecting a body fluid for testing for an analyte contained within said body fluid, said apparatus comprising:

a conduit having a first end for admitting a body fluid and transporting said body fluid from said first end to a discharge end of said conduit;

a reservoir for receiving and collecting a flow of body fluid from said discharge end of said conduit;

a test space positioned to be in contact with said fluid in said reservoir after said fluid has accumulated within said reservoir to a transfer volume of fluid, said test space positioned for said fluid in said test space to be exposed to analyte testing components;

said test space having a test space volume for residence of said fluid in said test space exposed to said components and with said transfer volume at least as great as said test space volume;

said test space adapted to passively wick said fluid from said reservoir into said test space at a rate of flow greater than a rate of flow of said fluid into said reservoir from said discharge end of said conduit when said fluid in said reservoir attains said transfer volume; and

said reservoir sized for fluid to flow into said reservoir from said conduit and be accumulated in said reservoir until attainment of said transfer volume.

2. An apparatus according to claim 1 wherein said reservoir and test space are arranged so that fluid flows from said reservoir to said test space upon accumulation of a volume of fluid in said reservoir being substantially equal to said transfer volume of fluid.

3. An apparatus according to claim 2 wherein said transfer volume of fluid is equal to or less than about 1 microliter.

4. An apparatus according to claim 1 wherein said reservoir has a volume and geometry so that fluid within said reservoir has a surface tension sufficient to retain the fluid within said reservoir regardless of the orientation of said reservoir.

5. An apparatus according to claim 1 wherein said conduit is in direct fluid communication with said reservoir.

6. An apparatus according to claim 5 wherein said reservoir is in direct fluid communication with said test space.

7. An apparatus according to claim 6 wherein said reservoir is in direct fluid communication with said test space volume.

8. An apparatus according to claim 1 wherein said test space is a capillary test space.

9. An apparatus according to claim 8 further comprising two opposing surface, said two opposing surfaces at least partially forming said capillary test space, said two opposing surfaces separated by a gap of about 0.3 mm or less.

10. An apparatus according to claim 9 wherein said gap between said two opposing being in said range from about 0.075 mm to about 0.125 mm.

11. An apparatus according to claim 8 further comprising:

test components within said capillary test space for testing said fluid for said analyte.

12. An apparatus according to claim 11 wherein:

said test components include electrodes for electro-chemically testing said fluid; and

said electrodes positioned within said capillary test space to be in contact with said fluid after said fluid is wicked into said capillary test space.

13. An apparatus according to claim 8 wherein said capillary test space is vented.

14. An apparatus according to claim 8 wherein material defining said capillary test space is more hydrophilic than material defining said reservoir.

15. An apparatus according to claim 1 wherein said test space is a capillary test space defined by an absorbent material in said test space to rapidly draw fluid from said reservoir into said capillary test space through passive capillary action.

16. An apparatus according to claim 1 wherein said test components are located within said test space for testing said fluid for said analyte.

17. An apparatus according to claim 16 wherein said test components include electrodes for electro-chemically testing said fluid, said electrodes positioned within said test space to be in contact with said fluid after said fluid is wicked into said test space.

18. An apparatus according to claim 1 wherein:

said conduit is a needle extending from a penetration end to said discharge end; and

said needle penetration end being exposed for penetration into a patient'"'"'s skin to access body fluid for said fluid to flow along said needle and discharged into said reservoir at said discharge end.